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Active Projects

This is the jumping-off point for all TLS drug development projects.

From here, you'll be able to access Project Portfolio for each drug candidate, where you'll have the opportunity to provide high-level input via TLS Protocol Builders, our crowdsourcing survey tool to develop clinical protocols . Each project has its own Protocol Builder that asks specific questions relating to each compound’s indication and trial design. Click on a project heading for more information.

We are beginning a second round of input for our Kiacta in sarcoidosis project.

Sarcoidosis is a disease of unknown origin with autoimmune features that causes granulomatous inflammation. It often affects the lungs and can cause pulmonary scarring. Kiacta is a compound developed by Auven Therapeutics for AA amyloidosis and sarcoidosis. TLS is assisting Auven on the sarcoidosis aspect of the program.

We submitted a draft protocol to the FDA in June 2015. The Agency has proposed certain changes to that protocol regarding study design and endpoints. In finalizing the design for this project, we would like the crowd to give us feedback through an updated Protocol Builder.

Key areas of the trial that we are looking for feedback include:

Overall Trial Design

Adaptive Design/Interim Analysis

Steroid Rescue

Protocol Builder Input Period Has Closed. Thank You for Participating.

Why Study Kiacta in Sarcoidosis?

TLS has begun a collaboration with Auven Therapeutics to develop Kiacta in sarcoidosis. Kiacta is a compound developed by Auven Therapeutics for AA amyloidosis and sarcoidosis. TLS is assisting Auven on the sarcoidosis aspect of the program.

Sarcoidosis is a disease of unknown origin with autoimmune features that causes granulomatous inflammation. It often affects the lungs and can cause pulmonary scarring.

The current treatments for pulmonary sarcoidosis include corticosteroids and immunomodulatory medications, which may cause severe side effects.

Kiacta is a molecule specifically designed to inhibit amyloid deposition into tissues. It presents the opportunity for a safer treatment than corticosteroids.

TLS is testing lisinopril as an adjunctive therapy in patients with MS; if clinical studies confirm its utility, as an inexpensive solution it might provide a real alternative for thousands suffering with MS

Please take part in designing an innovative clinical study of lisinopril in MS.

Protocol Builder Input Period Has Closed. Thank You for Participating.

Why metformin in prostate cancer?

Approximately 20-30% of men treated with surgery or radiation will develop recurrence of their prostate cancer, which most commonly manifests as a rising PSA level in the blood, commonly referred to as a “biochemical recurrence”.

This can occur many years before any evidence of cancer spread can be detected on imaging tests such as CT scans or bone scans.

Standard therapy for prostate cancer that has spread is treatment to lower the testosterone level in the body (aka, androgen deprivation therapy or ‘hormonal therapy’). This treatment has unfavorable side effects. Whether such treatment should be started for patients with a rising PSA, without any evidence of detectable spread on cancer on scans, is controversial.

Metformin is an oral drug used to treat diabetes. Several lines of evidence point to a potential for metformin to be effective in the treatment of prostate cancer.

Epidemiologic studies of patients with prostate cancer and diabetes have shown that patients taking metformin may have a lower likelihood of recurrence of the prostate cancer after surgery or radiation, and they may have a lower likelihood of dying of prostate cancer, when compared to patients not taking the drug.

Metformin can be tested for efficacy in patients with prostate cancer who experience a recurrence, as manifested by a rising PSA blood level after surgery or radiation. If clinical studies confirm its utility, it may provide an alternative for patients with prostate cancer, delaying or preventing the need for androgen deprivation therapy.

Please take part in designing an innovative clinical study of metformin in patients with recurrent prostate cancer, as manifested by a rising PSA blood test (biochemical recurrence), after surgery or radiation.